SIGNIFOR SOLUTION FOR INJECTION 0.6 mgml

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

Pasireotide diaspartate 0.75242mg eqv. Pasireotide

Commercializzato da:

PHARM-D SINGAPORE PRIVATE LIMITED

Codice ATC:

H01CB05

Dosaggio:

0.6 mg

Forma farmaceutica:

INJECTION, SOLUTION

Composizione:

Pasireotide diaspartate 0.75242mg eqv. Pasireotide 0.6 mg

Via di somministrazione:

SUBCUTANEOUS

Tipo di ricetta:

Prescription Only

Prodotto da:

Novartis Pharma Stein AG

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

2013-12-13

Foglio illustrativo

SIGNIFOR
®

DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORM 
Solution for injection 
ACTIVE SUBSTANCE 
Each ampule of 1 mL contains: 
Signifor
®
 0.3mg - 0.3 mg pasireotide (as diaspartate). 
Signifor
®
 0.6mg - 0.6 mg pasireotide (as diaspartate). 
Signifor
®
 0.9mg - 0.9 mg pasireotide (as diaspartate). 
Certain dosage strengths may not be available in all countries. 
ACTIVE MOIETY 
Pasireotide 
EXCIPIENTS 
Mannitol, tartaric acid, sodium hydroxide, water for injections.

INDICATIONS 
Treatment of patients with Cushing’s disease for
whom surgery is not an option or for whom 
surgery has failed.  
DOSAGE AND ADMINISTRATION 
DOSAGE 
GENERAL TARGET POPULATION
_ _
ADULTS  
The recommended initial dose of
Signifor is 0.6 mg by subcutaneous (s.c.) injection twice a 
day.  
Two months after the start of Signifor therapy, patients should
be evaluated for clinical 
benefit. Patients who experience a significant reduction
in urinary free cortisol [UFC] levels 
should continue to receive Signifor for as long as benefit is
derived. A dose increase to 0.9 mg 
may be considered based on the response to the treatment,
as long as the 0.6 mg dose is well 
Novartis   Page 
2 
Singapore-Specific Package Leaflet 
 04 Sep 2013 
Signifor
®

tolerated by the patient. Patients who
have not responded to Signifor after two months of 
treatment should be considered for discontinuation.  
Management of suspected adverse reactions at any time during the treatment may
require 
temporary dose reduction of Signifor.
Dose reduction by decrements of 0.3 mg twice a day is 
suggested. 
SPECIAL POPULATIONS

PATIENTS WITH RENAL IMPAIRMENT 
No dosage adjustment is required in patients with impaired renal
function (see section 
CLINICAL PHARMACOLOGY).

PATIENTS WITH HEPATIC IMPAIRMENT 
Dose adjustment is not required in patients with mildly impaired
hepatic f

Scheda tecnica

SIGNIFOR
®
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Solution for injection
ACTIVE SUBSTANCE
Each ampule of 1 mL contains:
Signifor
®
0.3mg - 0.3 mg pasireotide (as diaspartate).
Signifor
®
0.6mg - 0.6 mg pasireotide (as diaspartate).
Signifor
®
0.9mg - 0.9 mg pasireotide (as diaspartate).
Certain dosage strengths may not be available in all countries.
ACTIVE MOIETY
Pasireotide
EXCIPIENTS
Mannitol, sodium hydroxide, tartaric acid, water for injections.
Information might differ in some countries.
INDICATIONS
Treatment of patients with Cushing’s disease for whom surgery is not
an option or for whom
surgery has failed.
DOSAGE AND ADMINISTRATION
DOSAGE
GENERAL TARGET POPULATION
ADULT PATIENTS
The recommended initial dose of Signifor is 0.6 mg by subcutaneous
(s.c.) injection twice a
day.
Two months after the start of Signifor therapy, patients should be
evaluated for clinical benefit.
Patients who experience a significant reduction in urinary free
cortisol [UFC] levels should
continue to receive Signifor for as long as benefit is derived. A dose
increase to 0.9 mg
Novartis
Page 2
Singapore Specific Package Leaflet 13 Jan 2020 Signifor
®
may be considered based on the response to the treatment, as long as
the 0.6 mg dose is well
tolerated by the patient. Patients who have not responded to Signifor
after two months of
treatment should be considered for discontinuation.
Management of suspected adverse reactions at any time during the
treatment may require
temporary dose reduction of Signifor. Dose reduction by decrements of
0.3 mg twice a day is
suggested.
If a dose of Signifor is missed, the next injection should be
administered at the scheduled time.
Doses should not be doubled to make up for a missed dose.
SPECIAL POPULATIONS
PATIENTS WITH RENAL IMPAIRMENT
No dose adjustment is required in patients with impaired renal
function (see section CLINICAL
PHARMACOLOGY).
PATIENTS WITH HEPATIC IMPAIRMENT
Dose adjustment is not required in patients with mildly impaired
hepatic function (Child-Pugh
A). For patients